Cancer, Malnutrition, Nutrition Related Cancer
Conditions
Keywords
malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial
Brief summary
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
Detailed description
Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).
Interventions
DIETARY_SUPPLEMENTExperimental Group
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.
DIETARY_SUPPLEMENTControl Group
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Adventia Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
28 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over 18 with a cancer diagnosis (any type). * Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery. * Having lost more than 5% of body weight in the last 6 months. * Adequate cultural level and understanding for the clinical trial. * Signed informed consent.
Exclusion criteria
* Subjects who are participating in other clinical trials. * Subjects with morbid obesity. * Subjects who will undergo surgery or who will undergo. * Subjects with cachexia * Subjects with infection of a cause other than of the tumor * Subjects with an infectious process * Subjects with Diabetes Mellitus treated with insulin and/or not controlled * Subjects with kidney, heart, respiratory or liver disease. * Subjects with autoimmune diseases. * Subjects with mental illness or decrease function cognitive. * Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study. * Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month. * Patients who reject oral supplements. * Pregnant or breastfeeding women. * Allergic to any component of the formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | Change from baseline to day 142 | Subjective Global Assessment (SGA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet quality | Change from baseline to day 142 | 72h food registry questionaire |
| Functional status | Change from baseline to day 142 | Dinamometer |
| Eastern Cooperative Oncology Group Scale (ECOG) | Change from baseline to day 142 | Eastern Cooperative Oncology Group Scale (ECOG) |
| Body composition | Change from baseline to day 142 | BIA |
Countries
Spain
Outcome results
None listed